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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard  Food and Drug Administration (FDA) Final
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations  Food and Drug Administration (FDA) Final
Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff  Food and Drug Administration (FDA) Final
Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use  Food and Drug Administration (FDA) Final
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application  Food and Drug Administration (FDA) Final
Rare Diseases: Considerations for the Development of Drugs and Biological Products  Food and Drug Administration (FDA) Final
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products  Food and Drug Administration (FDA) Final
Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)  Food and Drug Administration (FDA) Final
Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.